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CompletedNCT04640688Updated Mar 23, 2026

Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

An observational study in Obesity, sponsored by Methodist Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
75
Ages
18 Years and older
Sex
All
01

Study summary

This will be a prospective, registry study of an investigational procedure for at least 12 standard of care visits up to 1 year after subject consents for study. Subjects will be enrolled between 8/1/2018 and 8/1/2023. Subjects will undergo a clinically indicated endoscopic procedure and subsequent follow up clinic visits as part of their standard medical care.

Disclaimer: To undergo the procedure there is an out of pocket expense for $9000.

Read the detailed description

All procedures, barring research activities such as consenting and data collection from Electronic Health Record , will be either clinically indicated and/or standard of care. Subject data will be collected and recorded in a registry which will allow for the prospective review and collection of clinical data related to Endoscopic Sleeve Gastroplasty for safety and efficacy assessment.

Study duration: At least 12 standard of care visits up to 1 year for each subject.

Standard of care follow up visits for Endoscopic Sleeve Gastroplasty are usually 2 weeks, 3 months, 6 months and 12 months post procedure with the physician and 8 follow-up visits over the year with a dietitian. No additional research related visits will be requested. All data will be collected from Electronic Health Record.

Disclaimer: To undergo the procedure there is an out of pocket expense for $9000.

02

Conditions studied

  • Obesity

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03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 75 is below the median of 135 across 1,283 observational studies indexed under Obesity.

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Lead sponsor

Methodist Health System is the lead sponsor of 169 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients who undergo bariatric procedures at Methodist Dallas Medical Center

Inclusion criteria

  • Age 18 years or older
  • Able to comprehend and provided written informed consent
  • Willing to comply with the substantial lifelong dietary restrictions required by the procedure
  • History of failure with non-surgical weight-loss methods
  • Willing to follow protocol requirements, including providing informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling
  • Women of childbearing potential ( not post-menopausal or surgically sterilized) must agree to use adequate birth control methods

Exclusion criteria

Exclusion Criteria:

  • Below 18 years of age
  • Prohibitive anesthetic risk
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
75 participants (actual)
Target follow-up
2 Weeks
Patient registry
Yes

Interventions

  • ProcedureBariatric procedures

    510(k) summary K081853 dated June 26, 2008, Endoscopic Sleeve Gastroplasty lecture, Methodist Dallas Medical Center Endobariatric Pathway \& Endoscopic Sleeve Gastroplasty Procedure Description

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What researchers measure

Primary outcomes

  1. Weight loss

    Percentage of total and excess weight loss at 30 days, 3 months, 6 months and 12 months after procedure.

    Time frame: 8/1/2018 and 8/1/2023

Secondary outcomes

  1. Documentation of safety

    procedure readmission rate (in days)

    Time frame: 8/1/2018 and 8/1/2023

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Study locations

1 site
  • Methodist Dallas Medical Center
    Dallas, Texas 75023, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04640688
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Nov 23, 2020
Start date
Aug 27, 2018
Primary completion
Feb 9, 2026
Completion
Mar 9, 2026
Last update
Mar 23, 2026

Study contacts

Prashant Kedia, MD
principal investigator · The Methodist Hospital Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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